A multi-centre, open-label, phase II study of the safety, efficacy and pharmacokinetic (PK) profile of CAP-232 administered through continuous intravenous infusion in patients with metastatic kidney cancer

Caprion Pharmaceuticals Inc.0 sites40 target enrollmentNovember 28, 2006

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Not specified
Sponsor: Caprion Pharmaceuticals Inc.
Enrollment: 40
Status: Active, not recruiting
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

November 28, 2006

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Caprion Pharmaceuticals Inc.

Eligibility Criteria

Inclusion Criteria

•1\) Patients must have histologically confirmed stage IV kidney clear cell carcinoma.
•2\) Patients must have progressive disease after receiving a previous systemic therapy.
•3\) Patient must have progressive disease confirmed by 2 CT Scans or MRI performed within 6 months.
•4\) Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as \>20 mm with conventional techniques or as \>10 mm with spiral CT scan.
•5\) Patients must have an age \>18 years.
•6\) Patients must have life expectancy of greater than 3 months.
•7\) Patient must be at least 5 years free of any other cancer(s). Basal cell carcinoma, provided that is neither infiltrating nor sclerosing and carcinoma in situ of the cervix, is acceptable.
•8\) Patients must have ECOG performance status ? ?2 (Karnofsky 60%).
•9\) Patients must have normal organ and marrow function as defined below:
•Leukocytes \>3,000/mm3

Exclusion Criteria

•11\) Patients who have received any known medical treatment targeting cancer within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
•2\) Patients may not be receiving any other investigational agents at least 30 days prior to enrollment in the study or/and participate in another clinical trial.
•3\) Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
•4\) Patients with a history of allergic reactions attributed to compounds of similar composition to CAP\-232\. CAP\-232 consists of a heptapeptide (active ingredient) in an acetate buffered saline solution with mannitol (0\.2 M sodium acetate, 0\.2 M acetic acid, 3% mannitol).
•5\) Patient with past or current cancer other than kidney cancer, except for:
•Curatively treated non\-melanoma skin cancer
•In situ carcinoma of the cervix
•Other cancer curatively treated and with no evidence of disease for at least 10 years
•6\) Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
•7\) Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with CAP\-232, breastfeeding should be discontinued if the mother is treated with CAP\-232\.